MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 40CC IAB (CHINA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-01C
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 (event site name: (b)(6).Event site telephone: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the patient's puncture was normal and the intra-aortic balloon catheter was properly installed.However the bleeding occurred within 12 hours of use, and the balloon ruptured, causing blood to flow back.The intra-aortic balloon catheter was immediately replaced, and no harm was caused to the patient.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field: d1, d4 version or model number, catalog number, udi number.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g4 (pma/510k) g6, h2, h11.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: b4, d4 lot number, expiry date, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected field: d4 udi number.It was reported that during intra-aortic balloon (iab) therapy, the patient's puncture was normal and the intra-aortic balloon catheter was properly installed.However, the bleeding occurred within 12 hours of use, and the balloon ruptured, causing blood to flow back.The intra-aortic balloon catheter was immediately replaced.
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 40CC IAB (CHINA)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 23654082
• Report Number: 2248146-2025-0000777
• Device Sequence Number: 18616138
• Product Code: DSP
• UDI-Device Identifier: 10607567109343
• UDI-Public: (01)10607567109343(10)3000382866(17)270423(11)240325
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0480-01C
• Device Catalogue Number: 0684-00-0480-01C
• Device Lot Number: 3000382866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 01/20/2026; 01/20/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/20/2026; 01/20/2026; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 75 YR
• Patient Sex: Male